- Strong First Year for LINZESS® (linaclotide); Leading Indicators
Reinforce Significant Opportunity Ahead -
- Detailing Seven GI Clinical Development Programs with Multiple
Opportunities to Generate Proof of Concept Data over Next 24 Months -
CAMBRIDGE, Mass.--(BUSINESS WIRE)--
Pharmaceuticals, Inc. (NASDAQ:IRWD) will detail its strategy to
establish a leading gastrointestinal (GI) therapeutics company during
its Investor Day today in New York City. This strategy leverages
Ironwood's strong development and commercial capabilities in addressing
GI disorders as well as its pharmacologic expertise in guanylate cyclase
(GC) pathways, all of which is based on Ironwood's pioneering work
bringing forward LINZESS, the first FDA-approved product in a new class
of GI medicines called GC-C agonists.
"At Ironwood, we've had the privilege to successfully discover, develop
and commercialize LINZESS, a medicine that is already helping hundreds
of thousands of adult patients suffering from IBS-C or CIC. Our
commercial and R&D teams are both executing at a very high level: we are
working closely with our U.S. partner Forest to drive strong uptake of
LINZESS, and we are also building a robust pipeline of potential
treatments for other highly symptomatic GI conditions," said Peter
Hecht, chief executive officer of Ironwood Pharmaceuticals, Inc. "With
LINZESS well on its way to becoming a leading GI brand, we have both the
opportunity and the obligation to prioritize the areas of our business
that we believe will maximize value for patients and shareholders. We
will leverage our development and commercial expertise in an effort to
address patient needs across the upper and lower gastrointestinal tract,
and we will build on our deep pharmacologic expertise as we work to
unlock value from our GC research platform, with a goal of advancing
seven GI clinical development programs with multiple opportunities to
generate proof of concept data over the next 24 months."
To execute on its strategy, Ironwood will:
Leverage strong commercial capabilities
Advance robust GI pipeline and guanylate cyclase (GC) research
Prioritize investments in key value drivers
Ironwood and Forest Laboratories, Inc. introduced LINZESS in December
2012 for the treatment of adult patients with irritable bowel syndrome
with constipation (IBS-C) or chronic idiopathic constipation (CIC). In
its first year on the market, LINZESS has delivered strong results
across key leading indicators for commercial success, including
physician adoption and prescription rates, payer uptake and patient
As of November 15, 2013, more than 48,000 healthcare practitioners had
prescribed LINZESS since its launch, and prescribing is increasing month
over month. Approximately 75 percent of LINZESS claims were being paid
as of October 2013, with continued progress with the payer and with the
companies' automated copay assistance program. Additionally, patient
persistency is tracking 40 percent to 57 percent above that seen for
certain other prescription products in this category at this stage of
their launch. According to IMS Health, more than 190,000 unique patients
had filled a prescription for LINZESS through October 2013, with more
than 500,000 total prescriptions filled from launch through November
Ironwood and Forest believe LINZESS has the potential to continue to
help more adult patients and build a new category of primary care
products. The companies intend to:
Further engage adult patients through optimization of the marketing
mix and expanded direct-to-consumer education beginning in the first
half of 2014, seeking to encourage greater patient/physician dialogue.
Continue to engage with payers with the goal of further improving
unrestricted access for commercial plans and increasing the rate at
which claims are paid to greater than 80 percent.
Optimize the selling effort and maximize the efficiency of the sales
force by focusing on the highest prescribing physicians to further
accelerate product growth.
Explore opportunities to strengthen the clinical profile of LINZESS by
expanding its utility in additional labeled indications and
populations. Ironwood and Forest are working collaboratively to:
Initiate a Phase II clinical trial to study linaclotide in
opioid-induced constipation, which is expected to begin in the
first half of 2014.
Initiate a co-administration study of linaclotide and a proton
pump inhibitor, which is expected to begin in the second half of
2014, to explore the safety and efficacy of these two categories
of drugs when used together and to further investigate the
potential for a fixed-dose combination for symptoms of both
gastroesophageal reflux disease and IBS-C or CIC.
Establish an appropriate plan with the FDA to study
age-appropriate formulations of linaclotide in pediatric patients.
Continue their partnership with the National Cancer Institute
(NCI) on an ongoing NCI-funded Phase I biomarker study to evaluate
linaclotide's potential to prevent colorectal cancer.
Leverage Commercial Capabilities
Ironwood has built strong commercial capabilities across marketing,
reimbursement, patient engagement and sales, with a highly-skilled team
of clinical sales specialists who have built strong relationships with
both gastroenterologists and primary care physicians across the U.S.
These important Ironwood assets are a growth platform and are expected
to generate value with internally and externally developed new products
Advance Robust GI Pipeline and GC Research
Millions of patients suffer from highly symptomatic disorders of the
upper or lower gastrointestinal tract and many of these patients are
actively seeking care and new treatment options. Many GI disorders may
share an underlying physiological cause characterized by visceral
hypersensitivity and/or delayed motility - two key aspects that
linaclotide's proposed mechanism of action may address.
In addition to working to maximize the utility of linaclotide, Ironwood
is advancing multiple development programs aimed at leveraging its
expertise in clinical GI disorders:
- Linaclotide Colonic Delivery: targeted delivery of
orally-administered linaclotide to the distal small intestine and
colon designed to potentially enhance lower abdominal symptom relief
for IBS-C and CIC sufferers; providing the opportunity to investigate
optimizing the clinical profile of linaclotide for multiple GI
disorders with lower abdominal pain as a predominant symptom,
including other IBS subtypes, ulcerative colitis, and diverticulitis,
among others; plan to initiate Phase II clinical trial in mid-2015.
- IW-9179: GC-C agonist designed to target upper GI tract
conditions; Phase IIa clinical trial to evaluate IW-9179 as a
potential treatment for functional dyspepsia ongoing; plan to initiate
Phase IIa clinical trial to evaluate IW-9179 in patients with
gastroparesis in the first half of 2015.
- IW-3718: gastric retentive formulation of a bile acid
sequestrant; plan to initiate Phase IIa clinical trial in first half
of 2014 to assess utility in refractory gastroesophageal reflux
Building on Ironwood's pioneering research with linaclotide, GC-C and
other guanylate cyclases, the company is focusing its research efforts
on GC-C agonists and on a second GC that Ironwood has been targeting for
a number of years, soluble guanylate cyclase (sGC). sGC is a validated
mechanism with the potential for broad therapeutic utility and multiple
opportunities for product development based on Ironwood's expertise in
medicinal chemistry, formulation and modulating tissue distribution.
Ironwood expects to initiate an sGC clinical study in the first half of
2015. Priority potential indications for evaluation in the sGC program
include pulmonary arterial hypertension and other cardiovascular
Prioritize Investments Across Key Value Drivers
Ironwood is focusing its investments on its priority growth platforms.
The company reduced the net cash used in operating activities from $93
million in the first quarter of 2013 to $58 million in the third quarter
of 2013 and it expects this trend to continue through 2014 due to
revenue growth and expense management. Ironwood reiterated that its
projected 2014 LINZESS sales and marketing expenses with Forest are
between $250 million and $300 million, as previously stated.
While Ironwood is focused primarily on commercializing its products
within the U.S., the company is also establishing a strong global brand
and is collaborating with high performing partners to lead the
advancement of linaclotide in certain territories worldwide. Ironwood
has established linaclotide partnerships in Europe, China, Japan, Canada
and Mexico. Ironwood will continue to evaluate opportunities to
establish partnerships in its un-partnered territories.
Ironwood will host a live webcast of its Investor Day, beginning at 8:30
a.m. Eastern Time, on Thursday, December 12. To access the webcast,
please visit the Investors section of Ironwood's website at www.ironwoodpharma.com
at least 15 minutes prior to the start of the event to ensure adequate
time for any software downloads that may be required. A replay of the
webcast will be available on Ironwood's website for 90 days following
About LINZESS (linaclotide)
LINZESS is the first and only guanylate cyclase-C (GC-C) agonist
approved by the FDA for the treatment of both irritable bowel syndrome
with constipation (IBS-C) and chronic idiopathic constipation (CIC) in
adults. LINZESS is a once-daily capsule that helps relieve the abdominal
pain and constipation associated with IBS-C, as well as the
constipation, infrequent stools, hard stools and incomplete evacuation
associated with CIC. The recommended dose is 290 mcg for IBS-C patients
and 145 mcg for CIC patients. LINZESS should be taken at least 30
minutes before the first meal of the day.
LINZESS is thought to work in two ways based on nonclinical studies.
LINZESS binds to the GC-C receptor locally, within the intestinal
epithelium. Activation of GC-C results in increased intestinal fluid
secretion and accelerated transit and a decrease in the activity of
pain-sensing nerves in the intestine. The clinical relevance of the
effect on pain fibers, which is based on nonclinical studies, has not
In placebo-controlled Phase III clinical trials of more than 2,800
adults, LINZESS was shown to reduce abdominal pain in IBS-C patients and
increase bowel movement frequency in both IBS-C patients and CIC
patients. Improvement in abdominal pain and constipation occurred in the
first week of treatment and was maintained throughout the 12-week
treatment period. Maximum effect on abdominal pain was seen at weeks 6-9
and maximum effect on constipation occurred during the first week. When
a subset of LINZESS-treated patients in the trials were switched to
placebo, they reported their symptoms returned toward pretreatment
levels within one week, while placebo-treated patients switched to
LINZESS reported symptom improvements. LINZESS is contraindicated in
pediatric patients up to 6 years of age. The use of LINZESS in pediatric
patients 6 through 17 years of age should be avoided. In nonclinical
studies, administration of a single, clinically relevant adult oral dose
of linaclotide caused deaths in young juvenile mice. LINZESS has not
been studied in pediatric patients. In adults with IBS-C or CIC treated
with LINZESS, the most commonly reported adverse event was diarrhea.
Ironwood and Forest Laboratories, Inc. are co-promoting LINZESS in the
United States. Linaclotide is marketed by Almirall, S.A. for the
treatment of adults with moderate to severe IBS-C in Europe under the
brand name CONSTELLA®. Ironwood also has partnered with Astellas Pharma
Inc. for development and commercialization of linaclotide in Japan and
with AstraZeneca for development and commercialization in China.
About Ironwood Pharmaceuticals
Ironwood Pharmaceuticals (NASDAQ:IRWD) is focused on creating medicines
that make a difference for patients, building value to earn the
continued support of our fellow shareholders, and empowering our team to
passionately pursue excellence. We discovered, developed and are
commercializing linaclotide, which is approved in the United States and
Europe. Our pipeline priorities include exploring further opportunities
for linaclotide, as well as leveraging our therapeutic expertise in
gastrointestinal disorders and our pharmacologic expertise in guanylate
cyclases to address patient needs across the upper and lower
gastrointestinal tract. Ironwood was founded in 1998 and is
headquartered in Cambridge, Mass. Connect with us at www.ironwoodpharma.com
or on Twitter at www.twitter.com/ironwoodpharma;
information that may be important to investors will be routinely posted
in both these locations.
LINZESS® and CONSTELLA® are trademarks owned by Ironwood
Important Safety Information
WARNING: PEDIATRIC RISK
LINZESS is contraindicated in pediatric patients up to 6 years
of age. Use should be avoided in pediatric patients 6 through 17
years of age. In nonclinical studies, administration of a single,
clinically relevant adult oral dose of linaclotide caused deaths
in young juvenile mice.
LINZESS is contraindicated in pediatric patients up to 6 years of age.
LINZESS is contraindicated in patients with known or suspected
mechanical gastrointestinal obstruction.
Warnings and Precautions
LINZESS is contraindicated in pediatric patients up to 6 years of age.
In nonclinical studies, deaths occurred within 24 hours in young
juvenile mice (1 to 3 week-old mice; approximately equivalent to human
pediatric patients less than 2 years of age) following administration
of one or two daily oral doses of linaclotide.
Use of LINZESS should be avoided in pediatric patients 6 through 17
years of age. Linaclotide did not cause deaths in older juvenile mice
(approximately equivalent to humans age 12 to 17 years). Although
there were no deaths in older juvenile mice, given the deaths in young
juvenile mice and the lack of clinical safety and efficacy data in
pediatric patients, use of LINZESS should be avoided in pediatric
patients 6 through 17 years of age.
Diarrhea was the most common adverse reaction of LINZESS-treated
patients in the pooled IBS-C and CIC double-blind placebo-controlled
trials. Severe diarrhea was reported in 2% of LINZESS-treated
patients. The incidence of diarrhea was similar in the IBS-C and CIC
Patients should be instructed to stop LINZESS if severe diarrhea
occurs and to contact their healthcare provider, who should consider
In IBS-C clinical trials, the most common adverse reactions in
LINZESS-treated patients (incidence ≥2% and greater than placebo) were
diarrhea (20% vs 3% placebo), abdominal pain (7% vs 5%), flatulence
(4% vs 2%), headache (4% vs 3%), viral gastroenteritis (3% vs 1%) and
abdominal distension (2% vs 1%).
In CIC clinical trials, the most common adverse reactions in
LINZESS-treated patients (incidence ≥2% and greater than placebo) were
diarrhea (16% vs 5% placebo), abdominal pain (7% vs 6%), flatulence
(6% vs 5%), upper respiratory tract infection (5% vs 4%), sinusitis
(3% vs 2%) and abdominal distension (3% vs 2%).
Please see full Prescribing Information including Boxed Warning: http://www.frx.com/pi/linzess_pi.pdf.
This press release contains forward-looking statements. Investors are
cautioned not to place undue reliance on these forward-looking
statements, including, but not limited to, statements about our
development and commercialization plans, and the investments associated
with those plans, for linaclotide and our product candidates and
programs in our pipeline; the anticipated timing of pre-clinical and
clinical developments, including clinical trials (and their associated
results); and our company's financial performance and results, including
our anticipated increased operating efficiencies and our projected 2014
sales and marketing expense for LINZESS®.Each forward‐looking
statement is subject to risks and uncertainties that could cause actual
results to differ materially from those expressed or implied in such
statement. Applicable risks and uncertainties include, but are not
limited to, those related to pre-clinical and clinical development,
regulatory approvals, manufacturing, formulation development,
intellectual property matters, efficacy, safety and tolerability,
competition in disease states, and the commercial potential of LINZESS
and our product candidates; the risk that our planned investments do not
have the anticipated effect on LINZESS or our company revenues; the risk
that we and our partner, Forest Laboratories, Inc., are unable to
commercialize LINZESS within the guided range of expenses; and the risk
that we are unable to effectively reduce our operating expenses to a
sufficient magnitude or for a sufficient period of time. Applicable
risks also include those that are listed under the heading "Risk
Factors" and elsewhere in Ironwood's Quarterly Report on Form 10‐Q for
the quarter ended September 30, 2013, in addition to the risk factors
that are listed from time to time in Ironwood's Annual Reports on Form
10‐K, Quarterly Reports on Form 10‐Q and any other subsequent SEC
filings. Ironwood undertakes no obligation to update these
forward-looking statements to reflect events or circumstances occurring
after this press release.Except as otherwise noted, these
forward-looking statements speak only as of the date of this press
release. All forward‐looking statements are qualified in their entirety
by this cautionary statement.
Source: Ironwood Pharmaceuticals, Inc.